Study of Obeldesivir to Treat Nonhospitalized Adults With Acute Respiratory Syncytial Virus (RSV) Infection
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: October 14, 2024
End Date: September 01, 2025
Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
1-833-445-3230 (GILEAD-0)
Inclusion Criteria:
- Exhibits at least 1 of the following risk factors for severe RSV disease:
1. Age ≥ 60 years
2. Moderate or severe chronic obstructive pulmonary disease (COPD) with a history of exacerbation during the preceding 12 months.
3. Asthma with a history of ≥ 1 exacerbation during the proceeding 12 months
4. One or more of the following chronic lung diseases:
- i) Bronchiectasis
- ii) Interstitial lung disease (eg, idiopathic pulmonary fibrosis)
- iii) Pulmonary hypertension
5. Chronic cardiovascular disease exclusive of hypertension
- RSV infection confirmed ≤ 3 days before randomization
- New onset or increased from baseline of ≥ 2 of the following signs and or/symptoms, and at least 1 sign/symptom of moderate severity a screening, and onset ≤ 3 days before randomization.
- RSV vaccine status:
- Individuals whose only risk factor is age ≥ 60 years must not have received any doses of a vaccine for RSV. Key
Exclusion Criteria:
- Currently requiring or expected to require hospitalization within 48 hours after randomization.
- Documented previous infection and/or hospitalization for RSV during the current respiratory virus season.
- Documented to be positive for influenza A or B virus, and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ≤ 7 days prior to randomization.
- Concurrent infections requiring treatment with any antimicrobial therapy ≤ 7 days prior to randomization.
- Individuals with a history of cystic fibrosis.
- Undergoing dialysis, known history of moderate or severe renal impairment within the preceding 6 months prior to randomization.
- Pregnant at screening.
- Received any approved or authorized, direct-acting antiviral drug or monoclonal antibody against RSV < 28 days or < 5 half-lives, whichever is longer, before randomization.
- Received an investigational product < 28 days or < 5 half-lives, whichever is longer, before randomization. Note: Other protocol defined Inclusion/Exclusion criteria may apply.